Nutrition Care Pharmaceuticals Pty Ltd operates within the complementary medicine industry, which in Australia is both highly regulated and very competitive. Our success largely depends on our ability to build customer loyalty and optimize the return on customer segments. Success is often dependent on getting new products into the market quickly and reimbursed at a price acceptable to both the marketplace and the organization. Our success also depends on a high level of market penetration and effective management of emerging and existing customers. This requires a high level of coordination between customers, sales and marketing and other internal stakeholders

POSITION OVERVIEW – Basic Function & Responsibility

Essential function(s) includes, but is not limited to: Ensure that Quality Control activities at NCP are performed in accordance Good Laboratory Practice (GLP) and the licensing requirements of the Therapeutic Goods Administration (TGA). Supervising the operation of the NCP Quality Control Laboratory and developing, implementing and reviewing all QC related documents and testing in compliance with TGA and product registration requirements.

Primary activities include, but are not limited to:

• Supervise & coordinate the QC Lab team and setting weekly work schedules for the QC Lab analysts.

• Managing and conducting raw material (RM) sample evaluations.

• Creating RM Specifications, reviewing and setting test methods and sampling plans after RM Evaluations.

• Assessment and Release of RMs for use in production, including assessment of potential shelf-life extensions.

• Conditional Release of RMs and bulk intermediate products after QC testing.

• Coordinating and assisting in QC Lab Equipment Qualification (IQ/OQ/PQ).

• Responsibility for QC Lab equipment maintenance (general) and calibration. • Planning, coordinating and implementation of QC Lab Test Method Validations. • Ensuring good documentation practices in the QC Lab.

• Overseeing Good Laboratory Practices (GLP) and training for QC Lab staff.

• Set & Maintain QC Lab Calibration Program.

• GMP Agreements with external (third party) laboratories; ensure these are accurate and current.

• Providing technical support/advice to QC Lab staff.

• When required, develop & monitor Quality Control procedures and lab methods for testing RM intermediates and/or for the finished products manufactured.

• Test RMs and Finished products to ensure compliance with TGA (Therapeutic Good Administration) or FSANZ (Food Standards Australia New Zealand)

Organisation and Efficiency

Coordinate daily activities to ensure key priorities are met in a timely manner.

Project leading/management as part of Operational Excellence programs and continuous improvement initiatives as directed by Quality Assurance Supervisor.

Communication

Provide information to request with the assurance that the data you deliver is valid.

Provide support to manufacturing and administration when requested.

Work as a team member, co-ordinate activities to enhance the performance of the group or project.

Staff Training

Provision of training/ assistance to staff members in accordance with NCP, Good Laboratory Practice (GLP) and other relevant quality standard requirements.

Attendance at agreed training courses (identified through Performance Appraisal or other appropriate methods).

Identification of own training needs.

Documentation

Maintain all documentation in accordance with Company and relevant quality standards.

Ensure all QC Lab SOPs are current and accurate, and assist in the development and revision of other QC/QA related SOPs.

Maintenance and Housekeeping

Ensure equipment used is clean and in safe working order at all times in accordance with Good Laboratory Practice (GLP).

Ensure good housekeeping in the area in accordance with NCP and relevant quality standards.

Safety, Health & Environment

Required to take reasonable care of your own health and safety and the health and safety of anyone else who may be affected by your acts or omissions in the workplace.

Co-operate with management with respect to action taken to comply with SHE requirements.

Contribute to the OH&S system by active identification of hazards and environmental risks.